Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS (Venus)

B

Boryung

Status and phase

Completed
Phase 3

Conditions

Poliomyelitis
Diphtheria
Pertussis
Tetanus

Treatments

Biological: DTaP vaccine and IPV vaccine
Biological: DTaP-IPV combination vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02458183
BR-DTPP-CT-301

Details and patient eligibility

About

The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

Full description

A multinational, multicenter, randomized, comparative, open-label, phase 3 study Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products

Enrollment

476 patients

Sex

All

Ages

7 to 10 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
  • Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
  • Male and female infants who are identified to be healthy based on physical examination and medical history.

Exclusion criteria

  • Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
  • Subjects who have moderate or severe acute disease (regardless of fever).
  • Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
  • Subjects who have major congenital defects.
  • Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
  • Subjects who have abnormalities in the immune system, or congenital/acquired immune deficiency.
  • Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
  • Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
  • Subjects who are allergic to the ingredients of the investigational products.
  • Subjects who have received immunoglobulins or blood products or plan to get those medications.
  • Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
  • Subjects who are currently participating or planning to participate in other clinical studies during the study period.
  • Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

476 participants in 2 patient groups

DTaP-IPV combination vaccine
Experimental group
Description:
Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of right thigh at the age of 2, 4, and 6 months
Treatment:
Biological: DTaP-IPV combination vaccine
DTaP vaccine and IPV vaccine
Active Comparator group
Description:
Product name: : Boryung DTaP Vaccine Inj. (Prefilled syringe) (Absorbed diphtheria, tetanus toxoid, and purified pertussis combination vaccine) Dosage and administration: A 0.5-mL dose is administered 3 times intramuscularly in the anterolateral aspect of right thigh at the age of 2, 4, and 6 months. Product name: IPVAX INJ. PREFILLED SYRINGE INJ. Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of left thigh at the age of 2, 4, and 6 months.
Treatment:
Biological: DTaP vaccine and IPV vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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